Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467))
8 juni 2018 uppdaterad av: AbbVie (prior sponsor, Abbott)
Humira 40 mg/0.8 mL Syringe for Subcutaneous Injection - Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)]
The present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
This survey was conducted to assess the risk and benefit of continuing or discontinuing biological therapy with adalimumab (Humira) during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859).
Studietyp
Observationell
Inskrivning (Faktisk)
220
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Anjo, Japan
- Site Reference ID/Investigator# 54680
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Aomori, Japan
- Site Reference ID/Investigator# 54677
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Chiba, Japan
- Site Reference ID/Investigator# 54516
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Chiba, Japan
- Site Reference ID/Investigator# 54660
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Chiba, Japan
- Site Reference ID/Investigator# 54683
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Fukuoka, Japan
- Site Reference ID/Investigator# 54521
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Gifu, Japan
- Site Reference ID/Investigator# 39854
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Hamamatsu, Japan
- Site Reference ID/Investigator# 54666
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Hiroshima, Japan
- Site Reference ID/Investigator# 54682
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Hyogo, Japan
- Site Reference ID/Investigator# 54669
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Hyogo, Japan
- Site Reference ID/Investigator# 54674
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Ibaraki, Japan
- Site Reference ID/Investigator# 54653
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Kagoshima, Japan
- Site Reference ID/Investigator# 54670
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Kagoshima, Japan
- Site Reference ID/Investigator# 54692
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Kawagoe, Japan
- Site Reference ID/Investigator# 54679
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Kawagoe, Japan
- Site Reference ID/Investigator# 59580
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Kawasaki, Japan
- Site Reference ID/Investigator# 54662
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Kirishima, Japan
- Site Reference ID/Investigator# 54693
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Kitakyushu, Japan
- Site Reference ID/Investigator# 54671
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Kumamoto, Japan
- Site Reference ID/Investigator# 54643
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Kyoto, Japan
- Site Reference ID/Investigator# 59583
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Maebashi, Japan
- Site Reference ID/Investigator# 59582
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Matsumoto, Japan
- Site Reference ID/Investigator# 39849
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Matsuyama, Japan
- Site Reference ID/Investigator# 54520
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Miyazaki, Japan
- Site Reference ID/Investigator# 54644
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Morioka, Japan
- Site Reference ID/Investigator# 54645
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Nagano, Japan
- Site Reference ID/Investigator# 54654
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Nagaoka, Japan
- Site Reference ID/Investigator# 54656
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Nagasaki, Japan
- Site Reference ID/Investigator# 63052
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Nagoya, Japan
- Site Reference ID/Investigator# 54667
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Nagoya, Japan
- Site Reference ID/Investigator# 54673
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Nara, Japan
- Site Reference ID/Investigator# 54649
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Niigata, Japan
- Site Reference ID/Investigator# 39844
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Oita, Japan
- Site Reference ID/Investigator# 54675
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Okayama, Japan
- Site Reference ID/Investigator# 39847
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Okayama, Japan
- Site Reference ID/Investigator# 54681
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Osaka, Japan
- Site Reference ID/Investigator# 39846
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Osaka, Japan
- Site Reference ID/Investigator# 54518
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Rifu, Japan
- Site Reference ID/Investigator# 54646
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Sagamihara, Kanagawa, Japan
- Site Reference ID/Investigator# 54661
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Saitama, Japan
- Site Reference ID/Investigator# 54514
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Saitama, Japan
- Site Reference ID/Investigator# 54689
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Sapporo, Japan
- Site Reference ID/Investigator# 25922
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Sapporo, Japan
- Site Reference ID/Investigator# 39850
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Sapporo, Japan
- Site Reference ID/Investigator# 54651
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Sapporo, Japan
- Site Reference ID/Investigator# 54652
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Sasebo, Japan
- Site Reference ID/Investigator# 54522
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Setouchi, Japan
- Site Reference ID/Investigator# 54650
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Shimotsuke, Japan
- Site Reference ID/Investigator# 39851
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Shizuoka, Japan
- Site Reference ID/Investigator# 39845
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Shizuoka, Japan
- Site Reference ID/Investigator# 54517
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Takamatsu, Japan
- Site Reference ID/Investigator# 59579
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Takasaki, Japan
- Site Reference ID/Investigator# 54655
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Tenri, Japan
- Site Reference ID/Investigator# 54519
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Tokorozawa, Japan
- Site Reference ID/Investigator# 54515
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Tokyo, Japan
- Site Reference ID/Investigator# 39842
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Tokyo, Japan
- Site Reference ID/Investigator# 39852
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Tokyo, Japan
- Site Reference ID/Investigator# 39853
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Tokyo, Japan
- Site Reference ID/Investigator# 54647
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Tokyo, Japan
- Site Reference ID/Investigator# 54657
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Tokyo, Japan
- Site Reference ID/Investigator# 54658
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Tokyo, Japan
- Site Reference ID/Investigator# 54678
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Tokyo, Japan
- Site Reference ID/Investigator# 54688
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Tokyo, Japan
- Site Reference ID/Investigator# 59581
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Tomigusuku, Japan
- Site Reference ID/Investigator# 54672
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Toyama, Japan
- Site Reference ID/Investigator# 54648
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Toyama, Japan
- Site Reference ID/Investigator# 54691
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Toyoake, Japan
- Site Reference ID/Investigator# 54690
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Toyohashi, Japan
- Site Reference ID/Investigator# 54676
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Tsu, Japan
- Site Reference ID/Investigator# 54668
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Yokohama, Japan
- Site Reference ID/Investigator# 39843
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Yokohama, Japan
- Site Reference ID/Investigator# 54663
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Yokohama, Japan
- Site Reference ID/Investigator# 54664
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Yokohama, Japan
- Site Reference ID/Investigator# 54665
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Yotsukaido, Japan
- Site Reference ID/Investigator# 54659
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study.
Beskrivning
Inclusion Criteria:
- The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study and provided informed consent to participate in the present follow-up survey.
Exclusion Criteria:
- Participants who used biological agents other than adalimumab after the period of treatment in the NCT00870467(M06-859) study were excluded from the present follow-up study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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Adalimumab
Participants who continued adalimumab treatment after completion of Study NCT00870467 (M06-859)
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Non-Adalimumab
Participants who discontinued adalimumab treatment after completion of Study NCT00870467(M06-859)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Disease Activity Score (DAS28)
Tidsram: Weeks 0, 26, and 52
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The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis.
Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR).
DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
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Weeks 0, 26, and 52
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Matrix Metalloprotease-3 (MMP-3)
Tidsram: Weeks 0, 26, and 52
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MMP-3 level in serum.
Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)
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Weeks 0, 26, and 52
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Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52
Tidsram: Week 0 to Week 52
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Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease.
Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]).
Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]).
Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
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Week 0 to Week 52
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Health Assessment Questionnaire Disability Index (HAQ-DI)
Tidsram: Weeks 0, 26, and 52
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Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity.
Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire.
Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.
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Weeks 0, 26, and 52
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Number of Participants With Adverse Events (AEs)
Tidsram: Week 0 to Week 52
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Adverse events (AEs) were collected from week 0 till the end of the study.
Please see Adverse Event section below for more details.
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Week 0 to Week 52
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Aki Kuroki, AbbVie GK.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2010
Primärt slutförande (Faktisk)
1 oktober 2012
Avslutad studie (Faktisk)
1 oktober 2012
Studieregistreringsdatum
Först inskickad
14 juli 2010
Först inskickad som uppfyllde QC-kriterierna
14 juli 2010
Första postat (Uppskatta)
15 juli 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 juli 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 juni 2018
Senast verifierad
1 december 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P12-069
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .